EXHIBIT 10.10
MANUFACTURING, SUPPLY AND DISTRIBUTION AGREEMENT
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THIS AGREEMENT (hereinafter "Agreement") is entered into as of the
Effective Date by and between ▇▇▇▇▇▇▇ Medizintechnik GmbH., a German
corporation, (hereinafter "▇▇▇▇▇▇▇"), and VisiJet, Inc., an United States
Delaware corporation (hereinafter "VisiJet"), and will come into power and be a
binding agreement upon the Effective Date set forth in Section 1.8 of this
Agreement.
WHEREAS, subject to terms and conditions described in this Agreement,
VisiJet desires to be appointed an exclusive distributor of ▇▇▇▇▇▇▇ to purchase,
market and sell certain products manufactured by ▇▇▇▇▇▇▇, and ▇▇▇▇▇▇▇ is willing
and able to manufacture and supply such products to VisiJet; and
WHEREAS, in exchange for such appointment and the valuable prior
investments made by ▇▇▇▇▇▇▇, VisiJet is willing to pay ▇▇▇▇▇▇▇ consideration in
the form of cash and stock, as set forth in Section 2.1 hereof,
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, VisiJet and ▇▇▇▇▇▇▇ agree as
follows:
1. DEFINITIONS
The following terms shall have the meaning specified in this Section:
1.1 "Accessories" shall mean the individual Product components set
forth in Schedule A
1.2 "Affiliate" shall mean corporations, partnerships or other
business entities, which, directly or indirectly are
controlled by, control, or are under common control with a
party to this Agreement.
1.3 "Annual Minimum" shall be defined in Schedule C hereafter.
1.4 "Annual Forecast" shall mean a non-binding production planning
forecast of VisiJet's estimated requirements for Products,
including both estimated quantities and delivery dates, during
a specified twelve (12) month period.
1.5 "Business Day" shall mean every day with the exception of
Saturday, Sunday or national holidays in the United States or
Germany.
1.6 "CE" shall mean an abbreviation of a French phrase "Conformite
Europeene". The marking indicates that the manufacturer has
conformed with all the obligations required by legislation.
1.7 "Confidential Information" shall mean the terms of this
Agreement and any information of a confidential and
proprietary nature disclosed by either party to the other
party in connection with this Agreement and identified in
writing as confidential and
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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proprietary, including, but not limited to, technical,
financial or commercial data, business plans and other
competitively sensitive information.
1.8 "Effective Date" is the date by which each party has fulfilled
its respective obligations at the closing, as set forth in
Section 18.10 hereof.
1.9 "FDA" shall mean the United States Food and Drug
Administration.
1.10 "Firm Orders" shall mean irrevocable, written purchase orders
for Products which specify the (i) Product(s), by SKU, as
defined in Schedule A, (ii) quantity to be delivered, (iii)
ship to location, (iv) designated carrier and (v) requested
delivery date.
1.11 "Product" and "Products" shall mean the EpiTome System and the
LasiTome systems as well as the parts, disposables and
accessories specifically associated with and intended for the
aforementioned systems as set forth in the schedule A.
1.12 "Master Artwork Text" shall mean the specific text for all
items of labeling, including but not limited to all packaging,
labels and markings to be provided by VisiJet and utilized by
▇▇▇▇▇▇▇ in connection with the manufacture of the Product.
1.13 "Non-Conforming Product" shall mean any Product which does not
conform to the Specifications, QSRs (Quality Service
Requirements) or other requirements of this Agreement at the
time of its manufacture.
1.14 "Specifications" shall mean the descriptions, criteria,
standards and other requirements set forth in the attached
Schedule A.
1.15 "Systems" shall mean the EpiTome System and the LasiTome
System more fully described in Schedule A.
1.16 "Term" shall have the meaning ascribed to it in Section 16.1.
1.17 "VisiJet Sales Affiliate" shall mean all sub distributors and
any other group, entity or individual with whom VisiJet enters
into a contract for the distribution and resale of Products.
1.18 "Year" shall mean consecutive twelve (12) month periods, with
Year 1 beginning on the Effective Day.
2. APPOINTMENT AS EXCLUSIVE DISTRIBUTOR; AMOUNT OF CONSIDERATION
2.1 EXCLUSIVE RIGHTS; CONSIDERATION. Subject to the terms and
conditions of this Agreement including, without limitation,
the closing conditions set forth in Section 18.10 hereof,
▇▇▇▇▇▇▇ shall appoint VisiJet as ▇▇▇▇▇▇▇'▇ exclusive
distributor as of the Effective Date to market, sell and
distribute the Products throughout the World ("Territory")
during the Term, and VisiJet shall (a) pay ▇▇▇▇▇▇▇ the
nonrefundable amount of [****] and (b) transfer to ▇▇▇▇▇▇▇, at
no cost to ▇▇▇▇▇▇▇, [****] shares of VisiJet Common Stock,
which VisiJet represents and warrants are duly authorized,
validly issued, and non-assessable. Except as shown on
Schedule 2.1, ▇▇▇▇▇▇▇ represents and warrants to VisiJet that
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it has not granted any other person or firm any license,
distribution or marketing rights with respect to the Products,
and the during the Term it will not grant any license,
distribution or marketing rights with respect to the Products
nor will it, directly or indirectly, market, sell or
distribute any of the Products during the Term.
2.2 [****] CLAIM. In order to enable ▇▇▇▇▇▇▇ to provide the
Products at the prices set forth in Schedule B, VisiJet will
reimburse ▇▇▇▇▇▇▇ for such amount as ▇▇▇▇▇▇▇ is required to
pay to obtain a reduction in royalties payable to [****] in
respect of U.S. Patent No. [****] and European Patent
Application No. [****] and related technology (the
"[****]Claim"), not to exceed [****] . Such reimbursement
shall be paid by VisiJet within 10 days after ▇▇▇▇▇▇▇ notifies
VisiJet in writing that it has settled the [****] Claim and
the amount that it is required to pay to [****] to secure such
settlement. The negotiations with [****] will be done by
▇▇▇▇▇▇▇ alone and neither VisiJet nor its affiliates shall
have any contact with [****]. In the event that the [****]
claims are not settled despite the best efforts of ▇▇▇▇▇▇▇, no
transfer of the [****] mentioned funds will be required, but
VisiJet agrees to an increase of the transfer price of the
Epitome and Lasitome systems as set forth in Schedule B by the
anticipated reduction of the amount to be realized by ▇▇▇▇▇▇▇
on sales of Products to VisiJet as a result of royalty fees
payable to [****], provided however that the cumulative total
of such increase in the transfer price to VisiJet shall not
exceed [****] .
2.3 VISIJET SUB-DISTRIBUTORS. VisiJet shall develop and maintain
sub-distributor relationships with individuals and companies
knowledgeable of the functional capabilities and operation of
the Products and the procedures in which they are used. Prior
to entering into any agreement with any subdistributor to
distribute or resell the Products, VisiJet shall provide to
▇▇▇▇▇▇▇ the proposed agreement and all information requested
by ▇▇▇▇▇▇▇ concerning the proposed distribution. ▇▇▇▇▇▇▇ and
VisiJet will mutually agree in advance on any proposed
sub-distribution agreement.
2.4 COMPETITIVE PRODUCT SALES. So long as VisiJet is a distributor
for ▇▇▇▇▇▇▇, VisiJet, its agents, employees, affiliates,
officers or directors shall not promote or sell any other
device which would be competitive to ▇▇▇▇▇▇▇'▇ Products as
listed in Exhibit A. Exceptions to this provision are
VisiJet's HydroKeratome waterjet microkeratome and the
PulsaTome cataract/lens removal device which are presently
under development by VisiJet.
3. VISIJET OBLIGATIONS AS DISTRIBUTOR
3.1 PURCHASE OF PRODUCTS: MINIMUM QUANTITIES. VisiJet shall
purchase Products from ▇▇▇▇▇▇▇ on the terms and conditions set
forth in this Agreement and shall use all commercially
reasonable efforts to maximize sales of the Products in the
Territory.
(i) After the six month period following the Effective
Date, VisiJet shall place Firm Orders each month of
not less than the minimum quantity requirements set
forth on attached Schedule C. Notwithstanding the
foregoing, for any Year in which VisiJet has already
submitted Firm Orders for the required Annual
Minimums set forth in Schedule C, for the remainder
of such Year: (a) the monthly Firm Orders required to
be submitted by VisiJet shall be reduced to [****] %
of the quantities set forth in Schedule C, and (b)
subsections (iii) and (iv) of this Section 3.1 shall
not apply.
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(ii) If, after the first [****] period following the
Effective Date, VisiJet fails to submit Firm Orders
within any month for at least [****] of the minimum
monthly quantities set forth in Schedule C, or if
VisiJet does not deliver a payment to ▇▇▇▇▇▇▇ of the
amount equal to the shortfall within [****] days
after the conclusion of such a month, then ▇▇▇▇▇▇▇
shall have the irrevocable right to terminate this
agreement without recourse upon [****] days prior
written notice.
(iii) If, after the [****] period following the Effective
Date, VisiJet does not submit Firm Orders within any
[****] consecutive months equal to [****] times the
minimum monthly quantities as set forth in Schedule
C, or if VisiJet does not deliver a payment to
▇▇▇▇▇▇▇ of the amount of the shortfall within [****]
days after the conclusion of the afore-mentioned
period of [****] consecutive months, then ▇▇▇▇▇▇▇
shall have the irrevocable right to convert VisiJet's
rights to market and distribute the Products to
non-exclusive rights upon [****] days prior written
notice.
(iv) In the event that, after the [****] period following
the Effective Date, VisiJet fails a second time to
submit Firm Orders within any [****] consecutive
months for the required accumulated minimum amount
equal to [****] times the minimum monthly quantities
as set forth in Schedule C, or if VisiJet does not
deliver a payment to ▇▇▇▇▇▇▇ of the amount of the
shortfall within [****] days after the conclusion of
the afore-mentioned period of [****] consecutive
months, then ▇▇▇▇▇▇▇ shall have the irrevocable right
to terminate this Agreement immediately without
recourse.
(v) ▇▇▇▇▇▇▇ shall notify VisiJet in writing of any
failure by VisiJet to place the required minimum
number of Firm Orders for any month within [****]
days after the end of the month in which such a
shortfall occurs.
(vi) VisiJet's monthly minimum obligations and ▇▇▇▇▇▇▇'▇
irrevocable rights under this Section shall not apply
in any Year in which one of the following has
occurred:
(a) Product recall, resulting from ▇▇▇▇▇▇▇'▇
design or manufacture of the Product;
(b) Failure by ▇▇▇▇▇▇▇ during such Year to
deliver at least [****] of Product on the
dates specified in VisiJet's Firm Orders, or
the delivery by ▇▇▇▇▇▇▇ of Non-Conforming
Products in any Product category, totaling
more than [****] of all Products in such
category delivered to VisiJet during such
Year; or
(c) Uncured material breach of this Agreement by
▇▇▇▇▇▇▇.
3.2 CERTAIN OTHER DUTIES OF VISIJET AS DISTRIBUTOR. VisiJet shall, at its
expense, be responsible for:
(i) All marketing decisions regarding the Products
including, but not limited to, labeling, packaging,
advertising, pricing, and with support and assistance
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of ▇▇▇▇▇▇▇, professional education. Notwithstanding
the foregoing, ▇▇▇▇▇▇▇ shall have the right and
responsibility to approve all labeling in order to
insure accuracy and legal compliance. ▇▇▇▇▇▇▇ will
not unreasonably withhold such approval and shall do
so on a timely basis.
(ii) Customer order processing, billing and collection of
payment for Products sold by VisiJet in the
Territory.
(iii) Preparing all promotional and educational materials
and conducting all promotional activities relating to
the Products sold by VisiJet in compliance with all
applicable laws and regulations of the Regulatory
Authorities in each country in the Territory. These
activities include but are not limited to the
following:
o Professional Journal Advertising
o Product Brochures
o Product Spec Sheets
o Sales Literature
o Physician Training Manuals
o Training Course Materials
o Sales Rep Training Manuals
o White Papers
o Symposium Papers
o Journal Reprints
o Promotional DVDs
o Round Table Panel Discussions
o Product Newsletters
o User Conference Manuals
o Website Content
o Direct Mail Promotions
o Internet Promotions
o Fax Blasts
o Scientific Conference Graphics and Panels
o Scientific Conference Promotional Materials
o Scientific Conference Signage
o Sales Rep Portable Booth Graphics
o Distributor Training Manuals
(iv) Establishing and maintaining a system of record
keeping, with the support and assistance of ▇▇▇▇▇▇▇,
including a register of lot numbers and individual
Product numbers and customer names and addresses for
all Product sold by VisiJet in order to assist
▇▇▇▇▇▇▇ with traceability in the event of a Product
recall. VisiJet shall require all of its customers
that are not the end users of Products, including all
VisiJet Sales Affiliates, to maintain a similar
register, including names and addresses of its end
users in accordance with all applicable state,
federal and country guidelines.
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(v) Conducting and continuing clinical trials for the
establishment, credibility and enhancement of the
EpiLASIK procedure and specifically for the
performance of the EpiTome product.
3.3 DEMO UNITS AND INITIAL ORDERS. VisiJet shall place Firm Orders
[****] days of the Effective Date for: (a) [****] demo units
of the EpiTome and LasiTome from ▇▇▇▇▇▇▇ for the purpose of
conducting physician clinical training and for demonstration
at major ophthalmic scientific conferences at a discount price
as outlined in Exhibit B, and (b) the first [****] Systems, to
be delivered by ▇▇▇▇▇▇▇ at no less than [****] per month after
its receipt of such Firm Orders. Such Systems shall conform to
the Specifications and satisfy all other conditions and
requirements set forth in this Agreement.
3.4 SERVICE ENGINEER. VisiJet shall at all times maintain at least
one service engineer trained in the repair and servicing of
▇▇▇▇▇▇▇'▇ products. VisiJet shall sponsor said engineer and
pay for all associated travel expenses for training in
▇▇▇▇▇▇▇'▇ headquarters in Neuhausen, Germany. Training shall
occur within [****] of the Effective Date of this Agreement.
4. VISIJET'S RIGHTS TO PURCHASE; ▇▇▇▇▇▇▇'▇ SUPPLY OBLIGATIONS
4.1 REQUIREMENTS. During the Term, VisiJet shall have the right to
purchase and ▇▇▇▇▇▇▇ shall manufacture and supply VisiJet's
requirements for the Products at such times and in such
quantities as specified by VisiJet in its Annual Forecasts and
amendments and Firm Orders as provided herein.
4.2 INVENTORY. Beginning six (6) months following the Effective
Date, ▇▇▇▇▇▇▇ will guarantee the availability of and maintain
in inventory [****] LasiTome/EpiTome Systems and all the
material for further [****] LasiTome/EpiTome Systems.
Additionally, ▇▇▇▇▇▇▇ will by the above mentioned time
guarantee the availability of and maintain in inventory [****]
LASIK-Blades, and [****] Epi-Blades.
4.3 ACCESSORIES. VisiJet shall have the right to purchase
Accessories on an as needed basis.
4.4 SOFTWARE UPGRADES AND IMPROVEMENTS. ▇▇▇▇▇▇▇ shall make
available to VisiJet, and VisiJet shall have the right to
market and sell, software upgrades and any improvements to the
Products or EpiTome Separator developed or acquired by ▇▇▇▇▇▇▇
during the Term. VisiJet shall be responsible for the
dissemination and any training relating to such software
upgrades or improvements.
4.5 SERVICE CONTRACTS. VisiJet shall have the right to offer its
consumers a service contract through ▇▇▇▇▇▇▇ and subject to
▇▇▇▇▇▇▇'▇ prior written approval to extend the one-year
warranty described in Section 11.2 for additional one-year
periods, subject to payment to ▇▇▇▇▇▇▇ of the fee for service
contracts set forth in Section 6.4 and such other terms and
conditions as the parties shall mutually agree. ▇▇▇▇▇▇▇ shall
provide, or arrange to provide through a mutually agreed upon
third party, service under the terms of such service
contracts.
5. FORECASTS, ORDERS, SHIPMENTS, ACCEPTANCE
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5.1 ANNUAL FORECASTS. VisiJet will provide ▇▇▇▇▇▇▇ with an initial
Annual Forecast upon execution of this Agreement and shall
update the Annual Forecast on a rolling basis no later than
[****] days prior to the first day of each subsequent Quarter.
5.2 FIRM ORDERS. VisiJet will provide ▇▇▇▇▇▇▇ with an initial Firm
Order upon execution of this Agreement on its written Purchase
Order Form by mail or fax (with original following by mail)
and paid for in accordance with the payment terms as specified
in Section 6.3 and will submit subsequent Firm Orders to
▇▇▇▇▇▇▇ at least [****] calendar days in advance of VisiJet's
requested delivery date. All Purchase Orders shall be
consistent with the provisions of this Agreement and any
inconsistent terms shall be deemed stricken.
5.3 MINIMUM ORDERS. In each three-month period (a "Quarter")
during the Term, VisiJet will submit Firm Orders for no less
than [****] of the quantities specified in the then current
Annual Forecast for such Quarter. ▇▇▇▇▇▇▇ shall not be
required to accept Firm Orders during any Quarter which, in
the aggregate, specify a quantity of Products greater than the
[****] of the quantity forecasted for such Quarter in the most
recent Annual Forecast. Yearly minimum purchases are defined
in Schedule C.
5.4 SHIPMENT. All prices for Product and Accessories are FOB
▇▇▇▇▇▇▇'▇ warehouse facilities in Germany. Title and risk of
loss or damages to the Products shall pass to VisiJet upon
▇▇▇▇▇▇▇'▇ delivery to VisiJet's designated carrier for
shipment. VisiJet shall bear any costs of shipment of Products
to VisiJet's warehouse or other designated location as well as
the amount of any and all taxes (other than income or
franchise taxes or duty imposed by the German government upon
▇▇▇▇▇▇▇), custom duties or other charges which may be required
to be paid or collected on the sale, delivery, or
transportation of the Products.
5.5 ORDER CANCELLATION. ▇▇▇▇▇▇▇ may cancel any accepted orders or
refuse or delay shipment of any orders if VisiJet fails to
meet any obligation arising under this Agreement.
6. PRICE AND PAYMENT
6.1 PURCHASE PRICE. The purchase price for the Products and
Accessories shall be as set forth in Schedule B.
6.2 PRICE INCREASES. The prices set forth in Schedule B shall
remain fixed until [****] . Thereafter, prices may be
increased effective [****] and on each subsequent [****]
during the Term by written notice delivered to VisiJet no
later than [****] of that calendar year during which the next
[****] price increase will become effective, provided that the
amount of such annual price increases shall not exceed [****]
percent ([****]%) of the then applicable prices.
6.3 PAYMENT TERMS. VisiJet shall pay [****] of the purchase price
for each System, Console or Handpiece ordered by VisiJet
together with submission of VisiJet's Firm Orders. VisiJet
shall pay the remaining [****] of the purchase price within
[****] days from the date of shipment of such Products in
accordance with Section 5.4. VisiJet shall pay the purchase
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price as set forth in Schedule B for all parts, disposables
and accessories within [****] days from the date of shipment.
6.4 SERVICE CONTRACTS. VisiJet shall pay ▇▇▇▇▇▇▇ a percentage of
all gross proceeds from all service contracts entered into by
VisiJet and approved in writing by ▇▇▇▇▇▇▇. Such payment shall
constitute full and final payment for all covered parts and
services to be provided under such Service Contracts,
including shipping costs to and from ▇▇▇▇▇▇▇. VisiJet and
▇▇▇▇▇▇▇ will mutually agree upon the pricing and other terms
of the Service Contracts, including but not limited to minimum
charges and the applicable percentage within three months of
the Effective Date, but in no case shall the applicable
percentage be less than [****] . Payment to ▇▇▇▇▇▇▇ shall be
made no later than the [****] day of the month for any service
contracts entered into by VisiJet and approved by ▇▇▇▇▇▇▇ in
the previous calendar month.
6.5 ACCESSORIES. VisiJet shall pay the purchase price for
Accessories within [****] days following the receipt of
shipment or receipt of invoice from ▇▇▇▇▇▇▇ whichever is
later.
6.6 ENGINEERING SERVICES. In the event ▇▇▇▇▇▇▇ provides
engineering services, VisiJet shall pay ▇▇▇▇▇▇▇ for such
services at an hourly rate of [****] and reimburse ▇▇▇▇▇▇▇ for
its reasonable out of pocket costs. Any amounts payable for
engineering services shall be payable within [****] days
following receipt of invoice for such services.
6.7 LATE PAYMENT CHARGES. Any amounts not paid by VisiJet when due
shall be subject to a late payment fee of [****] per month
until such amounts are paid in full.
6.8 SOFTWARE UPGRADES. VisiJet shall pay ▇▇▇▇▇▇▇ the greater of
(i) Fifty Percent (50%) of the gross sales price of all
software upgrades sold by VisiJet, or (ii) ▇▇▇▇▇▇▇'▇ standard
price for the software upgrade or improvement, payable by wire
transfer by the tenth day of each month for all software
upgrades sold in the previous month.
6.9 CURRENCY: All payments due hereunder shall be made in Euros to
▇▇▇▇▇▇▇ at its headquarters in Neuhausen, Germany, or such
other place as ▇▇▇▇▇▇▇ may designate. Currency conversion
rates are to be defined by rates published in THE WALL STREET
JOURNAL on the first day of the month prior to the payment due
date.
6.10 QUARTERLY STATEMENTS; AUDITS.
(i) Each party shall maintain books and records prepared
in accordance with international accounting standards
reflecting in a reasonable level of detail the data
utilized to calculate the amounts payable pursuant to
this Agreement for no less than two (2) years after
the end of each payment period.
(ii) Each party shall have the right, at its own expense
(except as otherwise provided below), to have the
other party's supporting books and records examined
during regular business hours upon reasonable advance
notice by such party or an internationally recognized
independent certified public accounting firm
designated by such party and reasonably acceptable to
the other party. The right of examination must be
exercised, with respect to any payment period, prior
to the expiration of the applicable two-year record
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retention period and shall not be exercised more
frequently than once each calendar year. Each person
participating in an examination shall agree not to
disclose any information obtained during such
examination which does not directly relate to the
calculation of the amounts payable under this
Agreement. If an examination results in the discovery
of an underpayment by one party to the other of
[****] or more of the amounts actually paid, the cost
of such examination shall be paid by the underpaying
party. Additionally, the underpaying party shall
immediately pay such shortfall plus any applicable
late payment charges.
7. INTELLECTUAL PROPERTY
7.1 OWNERSHIP. ▇▇▇▇▇▇▇ shall retain all rights, title and interest
in and to all intellectual property rights relating to the
Products. VisiJet shall have no right to modify or alter any
of the Products or Accessories in any way. Neither party shall
use any trade ▇▇▇▇ of the other party without the other's
prior written consent.
7.2 RESPONSE TO INFRINGEMENT. If either party becomes aware of any
infringement or threatened infringement of the patent rights
of ▇▇▇▇▇▇▇ for the Products, the party having such knowledge
will give notice to the other. ▇▇▇▇▇▇▇ shall have the
responsibility to take such action as it may deem necessary,
at its own expense, to prevent or eliminate such infringement.
The other party shall cooperate in any reasonable manner.
▇▇▇▇▇▇▇ shall not compromise or settle any suit for
infringement of its patent rights relating to the Products in
the Territory by providing a license to such infringing party
to sell the Products without the prior written approval of
VisiJet, which approval shall not be unreasonably withheld,
conditioned or delayed.
7.3 VISIJET SELF-HELP RIGHTS. In the event that ▇▇▇▇▇▇▇ does not
take any action to prevent or eliminate infringement of its
patent rights relating to the Products in the Territory within
[****] days after receipt of notice from VisiJet in accordance
with Section 7.3, VisiJet shall have the right to take all
reasonable and appropriate actions, including litigation, to
terminate such infringement. ▇▇▇▇▇▇▇ shall cooperate with
VisiJet, and execute any necessary documents relating to such
action. VisiJet shall not compromise or settle any suit for
infringement without the prior written approval of ▇▇▇▇▇▇▇,
which approval shall not be unreasonably withheld, conditioned
or delayed. ▇▇▇▇▇▇▇ shall reduce the transfer price for the
Products sold by VisiJet within the part of the Territory
subject to the infringement action by [****] % for the
duration of the litigation.
7.4 DAMAGE AWARDS. Any damages recovered by the party bringing the
action for patent infringement will be used first to
compensate that party for its out-of-pocket expenses in the
prosecution of any such action, suit or proceeding for
infringement. Any remaining damages recovered by that party
will be apportioned between VisiJet and ▇▇▇▇▇▇▇ in proportion
to the damage incurred by each party as a result of the
infringement.
8. THIRD PARTY RIGHTS
8.1 NOTICE OF CLAIMS. If either party becomes aware of any action,
or suit, or threat of action or suit, by a third party
alleging that the manufacture, use or sale or offer for sale
of the Products infringes a patent, or violates any other
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proprietary rights of any third party, such party will
promptly notify the other party of the same and fully disclose
all information relating thereto.
8.2 DEFENSE. ▇▇▇▇▇▇▇ shall use commercially reasonable efforts to
defend any such action relating to the Products. ▇▇▇▇▇▇▇ shall
cooperate and consult with VisiJet during the course of such
defense and shall keep VisiJet fully informed with respect to
all significant aspects of such action. VisiJet shall assist
▇▇▇▇▇▇▇ by providing information in the possession and control
of VisiJet and by providing such fact witnesses as may be
reasonably necessary to such defense.
8.3 JUDGMENTS AND SETTLEMENTS. If, by the terms of: (i) a
settlement of any claim against VisiJet or ▇▇▇▇▇▇▇, or (ii) a
judgment, decree or decision of a court, tribunal or other
authority of competent jurisdiction finding that the sale of
any of the Products infringed a patent, or violated any other
proprietary rights of any third party, and VisiJet is required
to compensate or pay damages to such third party, ▇▇▇▇▇▇▇ will
pay all such damages up to the amount paid by VisiJet to
▇▇▇▇▇▇▇ pursuant to this Agreement. In the event that VisiJet
is unable to continue to sell the Product in any country in
the Territory due to potential infringement of a third party's
rights, ▇▇▇▇▇▇▇ will, at its sole option and expense: (a)
replace or modify the infringing Product so that it becomes
non-infringing as long as functionality is not materially and
adversely affected; or (b) procure the right to continue
manufacturing and selling the Products; or (c) if ▇▇▇▇▇▇▇ is
unable to replace or modify the infringing Product or to
procure the right to continue to manufacture and sell the
Products on commercially reasonable terms, terminate the
Agreement and return to VisiJet a prorated portion of the one
million EURO payment required by Section 2.1 above based on
the remaining Term of the Agreement at the time of such
termination.
9. REGULATORY COMPLIANCE
9.1 PRODUCT REGISTRATIONS. ▇▇▇▇▇▇▇ shall obtain and maintain all
site licenses and regulatory approvals which may be or become
necessary to enable ▇▇▇▇▇▇▇ to manufacture and sell the
Products to VisiJet. ▇▇▇▇▇▇▇ shall maintain all device
registrations for the European Union and other countries that
are in existence at the time of signing of this agreement.
VisiJet will be responsible for obtaining and maintaining in
its own name and the name of ▇▇▇▇▇▇▇, or the name of a VisiJet
Affiliate and the name of ▇▇▇▇▇▇▇ all device registrations and
regulatory filings for any other country VisiJet wants to
market the products with ▇▇▇▇▇▇▇'▇ reasonable assistance. Each
party shall execute such documents and provide such
information to assist the other in obtaining or transferring
registrations in accordance with the terms of this Section 9.1
as may be reasonably requested by either party.
9.2 AUTHORIZED REPRESENTATIVE. For purposes of the European
Medical Device Directive (EEC93/42), ▇▇▇▇▇▇▇ shall be
designated as the Manufacturer of the Products and VisiJet,
Inc., shall serve as the Authorized Representative
9.3 AGENCY INSPECTIONS. ▇▇▇▇▇▇▇ will notify VisiJet of the outcome
of any inspection of ▇▇▇▇▇▇▇'▇ manufacturing or warehouse
facilities by the FDA, CE Notified Bodies, or any regulatory
agency of any other country and shall notify VisiJet within
five (5) Business Days of any regulatory action taken.
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10. QUALITY ASSURANCE AND IMPROVEMENTS
10.1 MASTER ARTWORK TEXT. VisiJet shall develop and provide the
Master Artwork Text in label or printed form no less than ten
(10) Business Days prior to the shipment of the demonstration
Systems referred to in Section 3.3 and Section 5.4 above.
VisiJet shall develop and provide ▇▇▇▇▇▇▇ with print quality
Master Artwork Text for use with all subsequent Products to be
delivered under this Agreement no less than twenty (20)
Business Days prior to the delivery date specified in
VisiJet's subsequent Firm Order. The Master Artwork Text, and
any subsequent revision thereto provided by VisiJet, shall
become incorporated as part of the Specifications and shall
not be altered in any way by ▇▇▇▇▇▇▇ without the prior written
consent of VisiJet.
10.2 PACKAGING. All Products shall be packaged in VisiJet's
designated packaging using VisiJet's designated brand names,
model numbers and Master Artwork Text and shall include a
mutually agreed upon reference to ▇▇▇▇▇▇▇.
10.3 QUALITY ASSURANCE. ▇▇▇▇▇▇▇ shall conduct quality testing on
the Products prior to delivery to VisiJet as set forth in the
Specifications and as required under the QSRs and shall
deliver to VisiJet concurrently with each shipment a
Certificate of Compliance stating that each Product shipped
has been produced in accordance therewith. ▇▇▇▇▇▇▇ shall
retain all manufacturing records for no less than ten (10)
years following the date of manufacture. ▇▇▇▇▇▇▇ shall
maintain documentation regarding each serialized unit and
software revision level (as applicable) for each Product
manufactured by or on behalf of ▇▇▇▇▇▇▇ hereunder.
10.4 ACCESS. VisiJet shall have access to all manufacturing records
within five (5) Business Days of any written request
therefore, provided that information requested by a CE
Notified Body, an authorized regulatory agency or by VisiJet
in the event of an emergency, will be provided within no more
than two (2) Business Days notice. VisiJet shall have the
right to conduct an annual audit of ▇▇▇▇▇▇▇'▇ and any contract
manufacturer's, manufacturing and warehouse facilities and
records to ensure that ▇▇▇▇▇▇▇'▇ quality assurance system is
effective and in accordance with the QSRs. VisiJet and its
authorized representatives shall have the right to inspect
such facilities during normal business hours with ten (10)
Business Days prior written notice, provided that in the event
that VisiJet determines, in its reasonable discretion, that an
onsite inspection is required in order to investigate a
specific quality concern or Product complaint, VisiJet shall
be entitled to conduct such an inspection upon two (2)
Business Days prior written notice.
10.5 MANUFACTURING CHANGES.
(i) SITE AND RESPONSIBILITY. ▇▇▇▇▇▇▇ shall not change the
site of manufacture of the Products without VisiJet's
prior written approval, which shall not be
unreasonably withheld or delayed. ▇▇▇▇▇▇▇ shall not
assign or subcontract manufacturing responsibility
without VisiJet's prior written approval, which shall
not be unreasonably withheld or delayed. For purposes
of this Section, the "site of manufacture" and
"manufacturing responsibility" shall mean the
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location and responsibility for the final assembly
and quality testing of the Products.
(ii) METHODS. ▇▇▇▇▇▇▇ shall not substantively change the
methods of manufacture relied upon by VisiJet for
qualification without VisiJet's prior written
consent, which consent shall not be unreasonably
withheld or delayed.
(iii) MATERIALS AND SUPPLIERS. ▇▇▇▇▇▇▇ shall provide
VisiJet with a ▇▇▇▇ of materials and list of
suppliers for each Product, which information shall
be deemed Confidential Information of ▇▇▇▇▇▇▇.
▇▇▇▇▇▇▇ shall notify VisiJet of any proposed
substitution of any critical materials or suppliers
at least five (5) Business Days prior to
implementation of such change. In the absence of any
reasonable objection from VisiJet prior to the
expiration of such notice period, ▇▇▇▇▇▇▇ shall be
free to implement the change identified in such
notice. The parties shall identify a list of
materials and supplies which can be substituted or
sourced from alternate suppliers without notice to or
consent by VisiJet.
(iv) MANUFACTURING IMPROVEMENTS. The parties shall work
together to reduce manufacturing costs and to improve
yields, quality and performance. VisiJet shall have
the right to request that the Products be sourced by
▇▇▇▇▇▇▇ through a third party, provided that such
outsourcing reduces ▇▇▇▇▇▇▇'▇ cost and, the parties
shall share any such cost savings equally by
corresponding adjustments to the purchase price
payable by VisiJet for such Products.
(v) SOFTWARE UPGRADES AND PRODUCT IMPROVEMENTS. ▇▇▇▇▇▇▇
shall make reasonable commercial efforts to provide
specific software upgrades or other Product
improvements requested by VisiJet. ▇▇▇▇▇▇▇ shall
exercise reasonable efforts to promptly correct and
provide customer solutions, at its own expense, for
any material errors identified by either party in the
operation of the software.
(vi) NEW APPLICATIONS. The parties agree to work together
in good faith to evaluate the opportunities for
developing additional applications for the Products.
11. REPRESENTATIONS AND WARRANTIES
11.1 ▇▇▇▇▇▇▇ WARRANTIES. ▇▇▇▇▇▇▇ hereby represents and warrants
that (i) all Products supplied by ▇▇▇▇▇▇▇ to VisiJet hereunder
shall have been manufactured, quality tested and packaged in
accordance with, and shall conform to, the Specifications, all
other requirements set forth in this Agreement and all laws
and regulations, including but not limited to the QSRs, as
such laws, regulations and requirements are constituted and
effective as of the time of shipment of the Products to
VisiJet, (ii) ▇▇▇▇▇▇▇ will maintain the integrity of the
practices and processes upon which VisiJet has relied for
qualification; and (iii) ▇▇▇▇▇▇▇ has capability and capacity
to perform all of it's obligations hereunder. ▇▇▇▇▇▇▇ hereby
represents and warrants that to the best of its knowledge it
is the sole owner of, or has the right to use, all
intellectual property necessary to develop and manufacture the
Products, and any other materials supplied by ▇▇▇▇▇▇▇ pursuant
hereto, and that neither the Products nor any trademarks or
designs used in connection therewith infringe any patent,
copyright, trademark or other similar proprietary right of any
person.
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11.2 PRODUCT WARRANTIES. ▇▇▇▇▇▇▇ warrants that it will use
commercially reasonable care in the manufacture of the
Products and that such Products shall be free from material
defects in materials and workmanship under normal use and
service. ▇▇▇▇▇▇▇'▇ obligations under this warranty shall be
limited to replacement of any Product which is determined to
be Non-Conforming within one (1) year from the date of
original shipment to VisiJet.
11.3 VISIJET REPRESENTATIONS AND WARRANTIES. VisiJet represents and
warrants that it has the resources, capability and capacity to
perform its obligations hereunder. VisiJet also represents and
warrants that it shall, obtain within [****] of the Effective
Date, no less than [****] in net proceeds from an offering of
its equity securities, to fund its ongoing operations and
business activities. VisiJet acknowledges that in the event of
a breach of this representation, ▇▇▇▇▇▇▇ shall have the right
to immediately terminate this Agreement.
12. RECALLS, COMPLAINTS, RETURNS AND SUPPLY FAILURE
12.1 NOTIFICATION. The parties shall immediately contact each other
in the event that either party has any reason to believe that
a voluntary withdrawal or recall of any Product may be
necessary. VisiJet and ▇▇▇▇▇▇▇ shall jointly confer and
cooperate to resolve any issues with respect to a voluntary
withdrawal or recall, including without limitation, the
necessity of declaring the voluntary withdrawal or recall, the
manner in which the voluntary withdrawal or recall should be
conducted and the duration of the voluntary withdrawal or
recall, provided that either party shall have the right to
require a voluntary withdrawal of any Product in the event of
a reasonable and good faith concern regarding the safety of
such Product. VisiJet shall be responsible for notification of
the applicable health authorities in the event of a voluntary
withdrawal or recall.
12.2 VISIJET RESPONSIBILITY. VisiJet shall be responsible for the
costs of a recall or voluntary withdrawal, and shall reimburse
▇▇▇▇▇▇▇ for any costs reasonably incurred by ▇▇▇▇▇▇▇, in the
event a recall or voluntary withdrawal which is determined, by
mutual agreement of the parties (or, if the parties fail to
agree, by arbitration pursuant to Section 18.6), to have been
caused by VisiJet's storage, promotion, packaging or
distribution of Products.
12.3 ▇▇▇▇▇▇▇ RESPONSIBILITY. ▇▇▇▇▇▇▇ shall be responsible for the
costs of a recall or voluntary withdrawal, and shall reimburse
VisiJet for any costs reasonably incurred by VisiJet in the
event a recall or voluntary withdrawal which is determined, by
mutual agreement of the parties (or by an independent third
party if the parties are unable to agree upon the cause), to
have been caused by a defect in the design or manufacture of
the Product.
12.4 MARKET COMPLAINTS. VisiJet shall establish and maintain an
appropriate system for collecting, recording and maintaining
market complaints relating to the Products, communicating
market complaint information to ▇▇▇▇▇▇▇, facilitating
corrective actions and product recalls. VisiJet will report
all Product or packaging-related complaints to ▇▇▇▇▇▇▇ within
ten (10) Business Days following receipt of the complaint.
▇▇▇▇▇▇▇ shall provide VisiJet with a written acknowledgement
of receipt of the complaint or suspected adverse incident and
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take appropriate investigative and, if necessary corrective
action, as required by the QSRs for the design and manufacture
of the applicable Product, and shall provide VisiJet with all
relevant information relating to any such investigation and
corrective action. VisiJet shall be responsible, in
consultation with ▇▇▇▇▇▇▇ for reporting any adverse incident
to the relevant regulatory authorities as required by the
QSRs.
12.5 RETURNS. VisiJet shall be responsible for responding to
inquiries or complaints concerning any Product and for the
collection and processing of any Products returned by
customers as defective. VisiJet shall return such Product to
▇▇▇▇▇▇▇ for evaluation. Any Product which is confirmed by
▇▇▇▇▇▇▇ to be Non-Conforming shall be repaired or replaced
without additional charge, including all shipping costs to and
from ▇▇▇▇▇▇▇. ▇▇▇▇▇▇▇ shall use reasonable commercial efforts
to repair or replace any Non-Conforming Products within twenty
(20) Business Days after receiving the Non-Conforming Product.
12.6 SUPPLY FAILURE. In the event that ▇▇▇▇▇▇▇ is unable for any
reason to supply at least [****] of VisiJet's Firm Orders for
Product in any two consecutive Quarters, VisiJet shall be
entitled to require ▇▇▇▇▇▇▇ to qualify a second source for the
manufacture of the Products on ▇▇▇▇▇▇▇'▇ behalf, subject to
all other terms and conditions of this Agreement. ▇▇▇▇▇▇▇
shall provide all manufacturing documentation and such other
assistance as may be necessary or useful to establish
manufacturing operations by such third party, subject to the
execution of appropriate non-disclosure restrictions. ▇▇▇▇▇▇▇
shall purchase the applicable Product(s) from such second
source and sell and deliver the Product(s) to VisiJet in
accordance with the provisions of, and at the prices set forth
in, this Agreement. ▇▇▇▇▇▇▇ shall ▇▇▇▇▇ the second source a
royalty-free, non-exclusive license to any intellectual
property rights necessary to enable the second source to
manufacture the Products until such time as ▇▇▇▇▇▇▇ is again
able to meet the requirements referenced above.
13. INDEMNIFICATION
13.1 Subject to the limitations set forth in Section 8 and Section
11 above, ▇▇▇▇▇▇▇ shall indemnify and hold harmless VisiJet,
its officers, agents and employees against any claim, loss,
damage, penalty, assessment or expense (including reasonable
attorneys fees) (a "Claim") arising directly or indirectly
from ▇▇▇▇▇▇▇'▇ (i) manufacture, testing, handling or storage
of the Product, (ii) breach of warranty, (iii) breach of any
of its other obligations under this Agreement; or (iv)
infringement of any intellectual property rights belonging to
any third party.
13.2 VisiJet shall indemnify and hold harmless ▇▇▇▇▇▇▇ and its
officers, agents and employees against any Claim arising
directly or indirectly from VisiJet's (i) handling or storage
or the Product, (ii) marketing, packaging, sale or
distribution of the Product, (iii) breach of any of its
obligations under this Agreement, (iv) breach of any of its
representations or warranties, or (v) infringement of any
intellectual property rights belonging to any third party.
13.3 In the event that either party (the "Indemnified Party")
receives notice of, or becomes aware of, a Claim for which the
Indemnified Party intends to seek indemnification hereunder,
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the Indemnified Party shall promptly provide the other party
(the "Indemnifying Party") with notice of such claim. The
Indemnifying Party shall have the right, at its option and its
own expense, to be represented by counsel of its own choice
and to defend against, negotiate, settle or otherwise deal
with any such Claim, provided the Indemnifying Party shall not
enter into any settlement or compromise of any such Claim
which could lead to liability or create any financial or other
obligation on the part of the Indemnified Party without the
Indemnified Party's prior written consent which consent shall
not be unreasonably withheld. The Indemnified Party may
participate in the defense of any Claim with counsel of its
own choice and at its own expense. The parties agree to
cooperate fully with each other in connection with the
defense, negotiation or settlement of any such Claim. In the
event that the Indemnifying Party does not undertake the
defense, compromise or settlement of a Claim, the Indemnified
Party may undertake such defense, compromise, or settlement,
but shall not settle or compromise any such claim with the
Indemnifying Party's prior written consent, which consent
shall not be unreasonably withheld.
13.4 NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL, INCIDENTAL,
INDIRECT OR CONSEQUENTIAL DAMAGES, OR FOR THE LOSS OF PROFIT,
REVENUE, OR DATA, ARISING OUT OF OR RELATING TO THIS AGREEMENT
EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF
SUCH POTENTIAL LOSS.
14. INSURANCE
During the term of this Agreement and for two (2) years thereafter
▇▇▇▇▇▇▇ shall maintain product liability insurance (containing a broad
form of vendors endorsements) on the Products with a minimum of [****]
for bodily injury, [****] for each claim and [****] for property
damage, and an aggregate limit of [****] . ▇▇▇▇▇▇▇ shall, upon
VisiJet's request, provide a Certificate of Insurance evidencing such
insurance.
15. CONFIDENTIALITY AND ANNOUNCEMENTS
15.1 During the Term of this Agreement and after the expiration or
termination of this Agreement, a party receiving (the
"Receiving Party") Confidential Information of the other party
(the "Disclosing Party") pursuant to this Agreement shall not:
(i) Use such Confidential Information for any reason
other than for the purpose of fulfilling the
Receiving Party's obligations and commitments under
the terms of this Agreement.
(ii) Disclose such Confidential Information to any person
other than employees of the Receiving Party who have
a need to know such information and to third parties
subject to written agreements prohibiting the
disclosure or use of such Confidential Information
other than for the purposes contemplated by this
Agreement.
(iii) Upon the Disclosing Party's request, the Receiving
Party shall return or destroy, at the Disclosing
Party's option, all materials, documents or records
incorporating the Disclosing Party's Confidential
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Information, provided that the Receiving Party shall
be entitled to retain one copy of such records for
archive purposes which shall remain subject to the
restrictions against use and disclosure set forth
herein.
15.2 The obligations set forth in Section 15.1 above shall not
apply to any information that the Receiving Party can show by
competent proof (i) was generally known to the public at the
time of disclosure by the Disclosing Party; (ii) becomes
generally known to the public thereafter through no act or
omission of the Receiving Party or its officers, employees,
agents, or representatives; (iii) was disclosed to the
Receiving Party by a third party having a bona fide right both
to possess the information and to disclose it to the Receiving
Party, or, (iv) is developed by the Receiving Party through
entirely independent efforts and without use of the
Confidential Information.
15.3 Neither party shall make any press release or trade
announcement relating to this Agreement, or otherwise disclose
the terms of this Agreement, without the prior written consent
of the other party, except as required by a court of competent
jurisdiction or pursuant to the disclosure requirements of a
governmental agency.
16. TERM AND TERMINATION
16.1 TERM. This Agreement will commence on the Effective Date and
will continue in effect for [****] from the Effective Date
(the "Initial Term") unless earlier terminated pursuant to the
provisions of the Agreement. VisiJet may at its election, upon
fifteen (15) days prior written notice to ▇▇▇▇▇▇▇ before the
end of the Initial Term, extend the term of this Agreement for
an additional [****] , provided that VisiJet has both: (a)
achieved a combined installed base of [****] Epi-Tome and
Lasi-Tome Systems within the Territory, and (b) sold at least
[****] Epi-Tome and Lasi-Tome blades during the preceding
[****] month period.
16.2 EARLY TERMINATION. One party may terminate this Agreement at
any time in the event of the other party's (i) failure to cure
any noncompliance with any material term of this Agreement
within [****] days following receipt of written notice of such
noncompliance, provided that any payment defaults must be
cured within [****] days following notice, or (ii) immediately
if the other party (a) terminates or suspends its business or
operations; (b) becomes subject to any bankruptcy or
insolvency proceeding under any applicable statute; (c)
becomes insolvent or subject to direct control by a trustee,
receiver or similar authority; or (d) has commenced the
process of winding up or liquidating.
16.3 EFFECT OF TERMINATION. In the event of termination of this
Agreement by VisiJet in accordance with Section 16.2, and
provided that VisiJet continues to be the exclusive
distributor of the Products through the termination date,
VisiJet will have the option to purchase any finished Product
inventory in ▇▇▇▇▇▇▇'▇ facilities on the termination date or
cancel any purchase order delivered prior to the date notice
of termination is given, provided that any Product ordered and
shipped prior to the effective date of termination which is
received by VisiJet shall be paid for in full by VisiJet in
accordance with the terms of this Agreement. In the event this
Agreement is terminated by ▇▇▇▇▇▇▇, all finished Products
manufactured and work in progress initiated pursuant to
Section 4.2 in response to Firm Orders submitted prior to the
effective date of termination shall be paid for in full by
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VisiJet in accordance with the terms of this Agreement.
VisiJet shall have the right to apply any unused portion of
the credit for prepaid inventory remaining under Section 6.3
of this Agreement against the total purchase price for any
Products delivered to VisiJet following termination.
17. FORCE MAJEURE
Neither party shall be liable to the other for loss or damages for any
default or delay attributable to any cause beyond the reasonable
control of that party, including, but not limited to an act of God,
flood, fire, explosion, strike war, acts or terrorism, governmental
action other regulatory enforcement action arising from any violation
of law, rule or regulation by the party seeking the protection of this
provision. If such an event occurs, the party affected shall notify the
other party and shall exercise diligent efforts to resume performance
of its obligations as soon as possible. In the event the party affected
is unable to resume performance within sixty (60) days, the other party
shall have the right to terminate this Agreement upon ten (10) days
prior written notice. Notwithstanding the foregoing, VisiJet's payment
obligations to ▇▇▇▇▇▇▇, with respect to Products and services
theretofore delivered by ▇▇▇▇▇▇▇, shall not be delayed or deferred by
any of the events referred to above.
18. MISCELLANEOUS
18.1 WAIVER. No waiver of any of the terms of this Agreement shall
be effective unless made in writing and signed by an
authorized representative of the party waiving its rights
hereunder.
18.2 NO LICENSE. No license to any trademark, patent, copyright or
other property right of ▇▇▇▇▇▇▇ is granted under this
Agreement except to the extent required for VisiJet to market
and sell the Products in accordance with the terms of this
Agreement.
18.3 GOVERNING LAW. This Agreement shall be construed and enforced
pursuant to the laws of the Federal State of
Baden-Wuerttemberg in Germany, disregarding any conflicts of
laws provisions.
18.4 INDEPENDENT CONTRACTORS. Nothing in this Agreement is intended
or shall be deemed to constitute a partnership, agency, or
joint venture relationship between the parties. All activities
by the parties hereunder shall be performed by them as
independent contractors. Neither party shall incur any debts
or make any commitments for the other party, except to the
extent specifically provided herein.
18.5 ASSIGNMENT. This Agreement shall be binding upon and inure to
the benefit of the parties, and permitted assigns. Neither
party may assign this Agreement without the prior written
consent of the non-assigning party, which consent shall not
unreasonably be withheld. In case of a proposed change of
control of VisiJet, and in consideration for ▇▇▇▇▇▇▇'▇ consent
and for the consequences to ▇▇▇▇▇▇▇ of such a change of
control, VisiJet will provide no less than [****] days notice
to ▇▇▇▇▇▇▇ of such proposed change of control event and
▇▇▇▇▇▇▇ shall have the right to require that VisiJet either
issue [****] shares of VisiJet at the cost of [****] per share
to ▇▇▇▇▇▇▇, or pay via wire transfer [****] to ▇▇▇▇▇▇▇'▇ bank
account immediately before such a change of control becomes
effective. As used in this section, the term "change in
control" means: (i) any merger, acquisition, sale of voting
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stock, or other transaction or series of related transactions
(the "Transaction") in which the shareholders of VisiJet
immediately before the Transaction (the "Original
Shareholders") do not collectively own a majority of the
outstanding shares of voting stock of the surviving
corporation immediately following the Transaction, or (ii) a
sale of all or substantially of the assets of VisiJet to a
person not an affiliate of VisiJet before such sale. For
purposes of determining whether a change in control has
occurred, any person that acquired shares of voting stock of
the surviving corporation in the Transaction, or whose
percentage ownership of such voting shares increased in the
Transaction, shall not be treated as an Original Shareholder.
18.6 ARBITRATION. In the event that the parties are unable to
resolve any dispute arising under this Agreement through
direct negotiations, the parties agree and consent to the
resolution of such dispute by binding arbitration. Any such
arbitration shall be conducted in accordance with the
procedures of the International Chamber of Commerce, or as
otherwise agreed by the parties, and shall be held in Federal
State of Baden-Wuerttemberg in Germany, before a single
arbitrator selected by the mutual agreement of the parties (or
by the International Chamber of Commerce, if the parties are
unable to agree upon an arbitrator). Notwithstanding the
foregoing, either party shall have the right to seek
injunctive relief in a court of competent jurisdiction to
prevent any breach of Sections 2.4, 7 and 15 of this Agreement
by the other party.
18.7 NOTICES. All notices hereunder shall be in writing and shall
be considered delivered on the day of hand delivery, one day
after delivery to a nationally recognized overnight delivery
service, charges prepaid, or three days-after being sent by
registered or certified mail, postage prepaid:
If to VisiJet, as follows:
VisiJet, Inc.,
▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇ ▇
▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
If to ▇▇▇▇▇▇▇, as follows
(i) ▇▇▇▇▇▇▇ Medizintechnik GmbH
▇▇▇▇▇▇▇▇▇▇. ▇/▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇
Attn: ▇▇. ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Or to such other address as any party shall have specified by
notice to the other in accordance with this paragraph.
18.8 COMPLIANCE WITH LAW. Each party shall comply with all legal
and regulatory requirements applicable to the conduct of its
business, including but not limited to, compliance with all
safety, health, environmental and employment laws applicable
to the activities to be undertaken by such party pursuant to
this Agreement.
18.9 ENTIRE AGREEMENT, MODIFICATION, COUNTER PARTS. The terms of
this Agreement represent the entire agreement of the parties
with respect to the subject matter herein and shall not be
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modified or supplemented except in a written document duly
executed by the parties expressly stating that it is intended
to modify, supplement or amend this Agreement. This Agreement
shall prevail in the event of any inconsistencies between it
and the terms of any purchase order, invoice or other form
utilized by the parties. This Agreement may be executed in one
or more counterparts, each of which shall be deemed an
original, but all of which together shall be deemed one and
the same instrument.
18.10 CLOSING. The closing of the transactions contemplated by this
Agreement shall take place at the offices of ▇▇▇▇▇▇▇▇▇▇▇ &
▇▇▇▇▇▇▇▇ LLP ("K&L") located at ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ on April __, 2004, or any
other date or place agreed to by the parties; PROVIDED THAT
for the purpose of defining the "Effective Date" and otherwise
making this Agreement legally binding, a closing shall be
deemed to have taken place ONLY IF each of the following
conditions are met: (a) VisiJet shall have delivered to K&L
(i) a cashier's check made out to K&L, or by wire transfer to
the account of K&L, in the amount of [****] , (ii) a stock
certificate evidencing the transfer of [****] shares of
VisiJet Common Stock to ▇▇▇▇▇▇▇, and (iii) two (2) original
signed signature pages to this Agreement; and (b) K&L, on
behalf of ▇▇▇▇▇▇▇, shall have delivered to VisiJet two (2)
original signed signature pages to this Agreement.
18.11 SEVERABILITY. Any term or provision of this Agreement that is
invalid or unenforceable in any situation in any jurisdiction
shall not affect the validity or enforceability of the
remaining terms or provisions hereof or the validity or
enforceability of the offending term or provision in any other
situation or in any other jurisdiction.
[THE REMAINDER OF THIS PAGE IS INTENTIONALLY LEFT BLANK.]
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IN WITNESS WHEREOF, the parties hereby execute this Agreement as of the
Effective Date.
▇▇▇▇▇▇▇ MEDIZINTECHNIK GMBH
By /S/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ Date May 7, 2004
-------------------
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, Managing Director
VISIJET, INC.,
By /S/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Date May 7, 2004
--------------------
▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, CEO
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SCHEDULE A
PRODUCT LIST
- EPITOME SYSTEM, INCLUDING:
CONSOLE
HANDPIECE
FOOTSWITCH X 2
EPI-HEAD X 2
RINGS X 4
METAL BANDS X 4
VACUUM HANDLES X 2
STERIBOXES X 2
- LASITOME SYSTEM, INCLUDING:
CONSOLE
HANDPIECE
FOOTSWITCH X 2
LASIK-HEAD X 2
RINGS X 4
METAL BANDS X 4
VACUUM HANDLES X 2
STERIBOXES X 2
- PARTS, DISPOSABLES AND ACCESSORIES WHICH BELONG TO THE EPITOME AND
LASITOME SYSTEMS, AS FOLLOWS:
LASIK-HEAD
EPI-HEAD
SUCTION RING
METAL BAND
VACUUM HANDLE
STERIBOX
HANDPIECE
CONSOLE
FOOTSWITCH
EPI-BLADE
LASIK BLADE
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SCHEDULE B
PRICE LIST
EpiTome/LasiTome System [****]
LASIK-Head [****]
Epi-Head [****]
Suction Ring [****]
Metal Band [****]
Vacuum Handle [****]
Steribox [****]
Sterilizable Cover
For Handpiece [****]
Handpiece [****]
Console [****]
Footswitch [****]
Epi-Blade [****]
LASIK-Blade [****]
EpiTome/LasiTome Demo System
Prices for each of the [****] Demo Systems
to be purchased by VisiJet
according to Sections 3.3 and 4 of the Agreement: [****]
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SCHEDULE C
MINIMUM ORDER QUANTITIES
PER MONTH PER YEAR
-----------------------------------
Epi-Tome Systems
OR [****] [****]
Lasi-Tome Systems
LASIK-Head
OR [****] [****]
Epi-Head
Epi-Blades [****] [****]
LASIK Blades [****] [****]
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SCHEDULE 2.1
▇▇▇▇▇▇▇ has entered into distribution agreements with the following entities for
the territories indicated:
[****]
▇▇▇▇▇▇▇ and VisiJet will use commercially reasonable efforts to cause these
distributors to become sub-distributors of VisiJet upon, or as soon as
practicable after, the Effective Date.
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